Back to jobsManage Computer System Validation (CSV) activities for GxP global computerized systems in compliance with regulatory requirements, industry standards and internal procedures.
Support projects from a CSV perspective, including:
Support the maintenance and continuous improvement of Global Quality Policies and Procedures related to CSV and ensure their consistent application across manufacturing sites and company affiliates.
Collaborate with Global Quality and Local Quality Teams during Regulatory Agency and Customer audits, providing CSV-related support and documentation.
Contribute to the company digital transformation program through the implementation of new electronic systems and upgrades of existing platforms.
Work closely with the IT Department to support business needs related to electronic systems, applications and digital tools.
Support data migration activities ensuring compliance, traceability and data integrity principles.
Ensure that computerized systems are maintained in a validated state throughout their lifecycle.
Participate in risk assessments, change controls, deviations and CAPA activities related to computerized systems.
Promote compliance with Data Integrity principles and applicable GxP requirements.
Job Description
- definition of validation strategies;
- review and approval of validation documentation;
- coordination of external consultants and vendors;
- oversight of validation activities throughout the system lifecycle.